Dr. Lalezari is the one who requested dosings in w
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Posted On: 01/17/2021 10:29:25 PM
Dr. Lalezari is the one who requested dosings in weeks 3 and 4 to be added (as he thought it would benefit the trial patients).
He made this request to the DSMC at our 50% Interim Analysis. According to Dr. Lalezari, he was told that adding the additional dosing was not necessary.
As far as finding mortality rates, there is nothing that has been unified amongst the various retrospective studies. I think that is one of the main problems with all the studies listed. These were not randomized (just retrospective). There were no unified standards to classify patients as belonging to moderate, severe, critical groups. So the stats seem nice, but nothing that really correlates the studies.
The only larger scale study I see, where we can obtain actual classifications to compare against our study is for Gilead's study with Remdesivir. Their study provides high quality randomized pts, across many trial sites, which allows for a better distribution than a single hospital. In their study, I'm looking at patients that were near the higher end of severe and critical population groups, which I'm classifying as patients who were using either: High Flow Nasal Cannula, Non-invasive Ventilation, Invasive Mechanical Ventilation, or ECMO. I am not including patients on basic supplemental oxygen, as that would decrease mortality significantly in this, and my goal is to look at the more severe patient groups.
Amongst that group, Gilead had 478 patients total (both Remdesivir and control arms combined). There was no difference in mortality between the groups, which is why I combined. Out of 478 patients, 96 died, which is a Mortality Rate of about 20%.
I don't think this is a great comparison to our trial though, as our patients were further along in the disease course, having tried multiple therapeutics (approved an experimental), before enrolling in our trial (since our drug was at the bottom of the list for trials, before Brian B. got us bumped to the top). Whereas, the Gilead pts were likely treated earlier the their disease progression making for an increased likelihood of improvement. Because of this, our mortality will be elevated quite a bit. The question is how much? That we don't know, but will find out soon enough.
He made this request to the DSMC at our 50% Interim Analysis. According to Dr. Lalezari, he was told that adding the additional dosing was not necessary.
As far as finding mortality rates, there is nothing that has been unified amongst the various retrospective studies. I think that is one of the main problems with all the studies listed. These were not randomized (just retrospective). There were no unified standards to classify patients as belonging to moderate, severe, critical groups. So the stats seem nice, but nothing that really correlates the studies.
The only larger scale study I see, where we can obtain actual classifications to compare against our study is for Gilead's study with Remdesivir. Their study provides high quality randomized pts, across many trial sites, which allows for a better distribution than a single hospital. In their study, I'm looking at patients that were near the higher end of severe and critical population groups, which I'm classifying as patients who were using either: High Flow Nasal Cannula, Non-invasive Ventilation, Invasive Mechanical Ventilation, or ECMO. I am not including patients on basic supplemental oxygen, as that would decrease mortality significantly in this, and my goal is to look at the more severe patient groups.
Amongst that group, Gilead had 478 patients total (both Remdesivir and control arms combined). There was no difference in mortality between the groups, which is why I combined. Out of 478 patients, 96 died, which is a Mortality Rate of about 20%.
I don't think this is a great comparison to our trial though, as our patients were further along in the disease course, having tried multiple therapeutics (approved an experimental), before enrolling in our trial (since our drug was at the bottom of the list for trials, before Brian B. got us bumped to the top). Whereas, the Gilead pts were likely treated earlier the their disease progression making for an increased likelihood of improvement. Because of this, our mortality will be elevated quite a bit. The question is how much? That we don't know, but will find out soon enough.
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